Keralyt Gel
NDC Package 11086-030-10

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Keralyt (salicylic acid) gel is a medication used on the skin to treat common skin and foot (plantar) warts. This formulation utilizes a gel delivery system. Marketed by Summers Laboratories Inc, this product is identified by NDC 11086-030.

Identification & Billing

NDC Package Code
11086-030-10
Package Description
100 g in 1 TUBE
Product Code
11086-030
11-Digit Billing Format
11086003010
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
100 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Keralyt
Non-Proprietary Name
Salicylic Acid
Substance Name
Salicylic Acid
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
SALICYLIC ACID 6 g/100g
Usage Information
This medication is used on the skin to treat common skin and foot (plantar) warts. Salicylic acid helps cause the wart to gradually peel off. This medication is also used to help remove corns and calluses. This product should not be used on the face or on moles, birthmarks, warts with hair growing from them, or genital/anal warts. Salicylic acid is a keratolytic. It belongs to the same class of drugs as aspirin (salicylates). It works by increasing the amount of moisture in the skin and dissolving the substance that causes the skin cells to stick together. This makes it easier to shed the skin cells. Warts are caused by a virus. Salicylic acid does not affect the virus.

Regulatory & Marketing

Labeler Name
Summers Laboratories Inc
Product Type
Human Prescription Drug
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
11-01-2009
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (11086-030). Click a package code to view its specific billing and regulatory data.

11086-030-60
60 g in 1 BOTTLE, WITH APPLICATOR

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 11086-030-10 identifies a specific commercial package of 100 g in 1 tube of Keralyt, a human prescription drug labeled by Summers Laboratories Inc. This product is billed per "GM" gram and contains an estimated amount of 100 billable units per package. This gel is formulated for topical use and contains salicylic acid as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Summers Laboratories Inc on November 01, 2009. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used on the skin to treat common skin and foot (plantar) warts. Salicylic acid helps cause the wart to gradually peel off. This medication is also used to help remove corns and calluses. This product should not be used on the face or on moles, birthmarks, warts with hair growing from them, or genital/anal warts. Salicylic acid is a keratolytic. It belongs to the same class of drugs as aspirin (salicylates). It works by increasing the amount of moisture in the skin and dissolving the substance that causes the skin cells to stick together. This makes it easier to shed the skin cells. Warts are caused by a virus. Salicylic acid does not affect the virus.

How is this Summers Laboratories Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 11086003010. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 100 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
11086-030-10
11-Digit CMS (5-4-2)
11086-0030-10

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.